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Nextech
EUDAMEDClass IIa (EU MDR)
Ref PCS21 (Secondary)Model Carbon Steel Surgical Blades-21 (size)
Identity
- Trade Name
- Nextech EUDAMED
- Device Name
- Carbon Steel Surgical Blades EUDAMED
- Model / Reference
- Carbon Steel Surgical Blades-21 (size) EUDAMEDPCS21 (Secondary) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18903175091530 EUDAMED
- Basic UDI-DI
- B-18903175091530 EUDAMED
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Manual scalpel blade, single-use
Nextech by Paramount Surgimed Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Manual scalpel blade, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18903175091530 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Paramount Surgimed Limited
- EUDAMED SRN
- IN-MF-000021682
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 815af9d9-f359-4ddb-b14d-518997d68b17 61 fields · synced Jun 19, 2026